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The SteriSpine™PS system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion.

SteriSpine™PS System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis; and failed previous fusion.

The cleared range of SteriSpineTM PS system include multiaxial screws and cannulated multiaxial screws with or without extended head (ø5.5, 6.5 and 7.5mm, lengths from 25 to 60 mm) and straight and prebent rods (ø 5.5, 6.5 and 7.5mm, lengths from 30 to 380 mm). Components of SteriSpineTM PS system are made of Titanium Ta6V Eli grade conforming to ASTM F136. The SteriSpineTM PS range of products is supplied sterile with a sterile single-use set of surgical instruments. The Percutaneous Ancillary Kit added within this submission include (trocar needle, dilators, rod measurer, protection sleeve, funnel body, funnel shaft and funnel impactor). These instruments are supplied as a sterile single-use set to be used with the previously cleared Ancillary Kits.

This document is a 510(k) premarket notification for a medical device called the SteriSpine™ PS Pedicle Screw. It seeks to establish substantial equivalence to a previously cleared predicate device.

Based on the provided text, there is NO study described that proves the device meets specific acceptance criteria in terms of performance (e.g., diagnostic accuracy, efficacy).

The "Discussion of Testing" explicitly states: "No testing has been performed for the added components."

This 510(k) submission is for the addition of a "Percutaneous Ancillary Kit" to an already cleared SteriSpine™ PS product range. The submission argues for substantial equivalence based on the intended use, material, design, mechanical properties, and function being similar to the predicate device, not on new performance studies for the added components.

Therefore, most of the requested information regarding acceptance criteria and performance studies cannot be extracted from this document, as such studies were not conducted or reported for this specific submission.

Here's an attempt to answer the questions based only on the provided text, acknowledging the significant limitations:

1. A table of acceptance criteria and the reported device performance

This information is not present in the document. The document states "No testing has been performed for the added components," meaning no performance criteria have been tested or reported for the new ancillary kit.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No performance testing involving a test set was conducted or reported for the added components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No performance testing was conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No performance testing was conducted.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a pedicle screw system and an ancillary kit, not an AI-based diagnostic tool. No MRMC study was conducted or reported.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a pedicle screw system and an ancillary kit, not an algorithm. No standalone performance study was conducted or reported.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No performance testing was conducted.

8. The sample size for the training set

Not applicable. This device is a pedicle screw system and an ancillary kit, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This device is a pedicle screw system and an ancillary kit, not an AI/ML model.

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The SteriSpine" PS system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion.

SteriSpine"PS System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis; and failed previous fusion.

system includes Pedicle Screws and Rods. Components SteriSpine™PS of SteriSpine™PS system are made of Titanium Ta6V Eli grade conforming to ASTM F136. SteriSpine™PS components are supplied sterile with a single-use set of surgical instruments. Components added within this submission include multi-axial pedicle screws with extended head and associated instruments.

This document describes a 510(k) premarket notification for a medical device, the "SteriSpine™ PS (Pedicle Screw) System." It is a class III device, which means it carries a higher risk than class I or II devices. The submission concerns a modification to an existing device (K112453 and K121299). The information provided is not for an AI/ML powered device, but rather a traditional medical device (pedicle screw spinal system). Therefore, several of the requested sections related to AI/ML device performance criteria, data provenance, expert ground truthing, and MRMC studies are not applicable.

Here's the breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: Not specified for mechanical or cadaver testing. For the clinical data, it states "Clinical data from a review of the literature has been presented in the class III summary," but no specific sample size from this literature review is provided in the extract.
• Data Provenance:
  • Mechanical Testing: Not specified (country of origin). This is typically performed in a lab setting.
  • Cadaver Testing: Not specified (country of origin).
  • Clinical Data: "a review of the literature" implies retrospective data, but the specific origins are not detailed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a traditional mechanical device, not one that relies on expert interpretation for ground truth. The "ground truth" here is adherence to mechanical standards and performance comparable to a predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study requiring adjudication of expert interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This is not an AI-powered device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm. The performance is the mechanical integrity of the device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is established through:

• Mechanical Standards: Adherence to ASTM F1717 and ASTM F1798 standards.
• Predicate Device Performance: Direct comparison of mechanical properties to the legally marketed predicate devices (SteriSpine™ PS K112453 and K121299).
• Cadaver Testing: Validation of instrumentation.

8. The sample size for the training set

Not applicable. This device does not use a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this type of device.

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